Phonak, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Phonak, Inc.” (first 1990, latest 2013), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 96 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 37 | 37 |
| EPF | Hearing Aid, Group And Auditory Trainer | 1 | 1 |
| KLW | Masker, Tinnitus | 1 | 1 |
Review panels
- Ear, Nose and Throat (39)
Most recent Phonak, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130790 | LYRIC2 | ESD | 2013-06-27 | 97 |
| K123450 | PHONAK TINNITUS BALANCE | KLW | 2013-02-11 | 94 |
| K972106 | PHONAK NOVO FORTE E3 | ESD | 1997-08-15 | 71 |
| K972105 | PHONAK EPICA | ESD | 1997-08-01 | 57 |
| K972097 | PHONAK MICROZOOM P 2 | ESD | 1997-07-30 | 56 |
| K964035 | PHONAK MICROLINK, PERSONAL FM RECEIVER | ESD | 1996-12-04 | 57 |
| K961653 | PHONAK SONA P2 | ESD | 1996-05-29 | 29 |
| K961622 | PHONAK PICONET2 P2 AZ | ESD | 1996-05-17 | 21 |
| K953921 | PHONAK 9900 CIC | ESD | 1995-09-18 | 28 |
| K945439 | PHONAK PICONET 232X-AZ HEARING INSTRUMENT | ESD | 1995-08-23 | 299 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Phonak, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Phonak, Inc.?
FDA lists 39 510(k) clearances under the applicant name “Phonak, Inc.” (first 1990, latest 2013), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Phonak, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phonak, Inc. is 50 days.
Which FDA product codes appear under Phonak, Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 37); EPF (Hearing Aid, Group And Auditory Trainer, 1); KLW (Masker, Tinnitus, 1).
Next steps
- See all 39 Phonak, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Phonak, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.